Gilead Sciences announced that the FDA has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. The FDA has set target review dates under the Prescription Drug User Fee Act (PDUFA) of October 3, 2014 for cobicistat and October 4, 2014 for elvitegravir.
Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In April 2013, the company received Complete Response Letters from the FDA. In its communications, the agency stated that it could not approve the cobicistat and elvitegravir applications in their current forms, citing deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during inspections. Gilead has worked with the FDA to address the questions raised in the Complete Response Letters.
Cobicistat and elvitegravir are components of Gilead’s Stribild ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a once-daily single tablet regimen for the treatment of HIV-1 infection. Stribild was approved in the United States in August 2012.
Cobicistat is approved under the tradename Tybost ® and elvitegravir is approved under the tradename Vitekta ® in Europe, Canada and Australia.